InfertilityNCT07478549
Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization
A study testing Standard Sperm Preparation and HyperSperm in people with Infertility, run by Fecundis Lab SL at 2 sites in Argentina.
Trial summary
Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Infertility
- What is being tested?
- Standard Sperm Preparation and HyperSperm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesArgentina
- Study dates
- Dec 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- General
- Couples undergoing in vitro fertilization (IVF) treatment.
- Planned use of fresh sperm samples obtained by masturbation.
- Female
- Age between 20 and 42 years.
- Antral follicle count ≥ 4.
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- Eligible for ovarian stimulation and embryo transfer.
- Male
- Age between 20 and 45 years.
- Fresh semen sample (not cryopreserved).
- Pre-processing sperm concentration ≥ 5 × 10⁶ sperm/mL.
Who cannot join
- General
- Active sexually transmitted infection (STI).
- Use of donor sperm.
- Medical conditions contraindicating pregnancy or the IVF procedure.
- Female
- Uterine anomalies associated with distortion of the uterine cavity.
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- Absence of one ovary or functional disorders preventing ovulation.
- Diabetes mellitus or other metabolic disorders.
- Recurrent pregnancy loss, defined as more than two clinical pregnancies without live birth.
- Male
- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina2 sites
IFER
Buenos Aires, Buenos Aires F.D., 1115
Fabian Lorenzo, MD, +54 9 11 6707-8521, fabian.lorenzo@hotmail.com
Pregna
Buenos Aires, Buenos Aires F.D., 1425
About this study
Official title: Prospective, Multicenter, Randomized Clinical Trial Evaluating the Safety of the HyperSperm Sperm Preparation Procedure.
Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.
- Conditions
- Infertility
- Being tested
- Standard Sperm Preparation, HyperSperm
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Sperm PreparationDevice
Standard sperm preparation
HyperSpermDevice
Multi-step sperm preparation
| Study group | Role | What they receive |
|---|---|---|
| Standard Sperm Preparation | Active comparator | Sperm samples in the control group will undergo traditional processing in the lab prior to insemination. Receives: Device: Standard Sperm Preparation |
| HyperSperm | Experimental | Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. Receives: Device: HyperSperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploidy Rate
Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.
Measured: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).
Secondary outcomes (10)
Clinical Pregnancy Rate
Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound.
Measured: 5-7 weeks of gestation following embryo transfer.
Fertilization Rate
Proportion of oocytes successfully fertilized following insemination during IVF.
Measured: Approximately 16-20 hours after insemination.
Cleavage Rate
Proportion of fertilized embryos progressing to the cleavage stage.
Measured: Day 2-3 after fertilization.
Blastocyst Formation Rate
Proportion of embryos that develop to the blastocyst stage.
Measured: Day 5-6 after fertilization.
Embryo Quality at Cleavage Stage
Embryo quality assessed according to standard morphological criteria at the cleavage stage.
Measured: Day 3 after fertilization.
Embryo Quality at Blastocyst Stage
Embryo quality assessed according to standard morphological criteria at the blastocyst stage.
Measured: Day 5-6 after fertilization.
Biochemical Pregnancy Rate
Proportion of participants with biochemical pregnancy, defined as a detectable increase in serum β-hCG concentration following embryo transfer.
Measured: Approximately 10-14 days after embryo transfer.
Progressive Motile Sperm Count After Processing
Number of progressively motile spermatozoa present after sperm processing.
Measured: Immediately after sperm processing on the day of oocyte retrieval.
Total Sperm Motility After Processing
Percentage of spermatozoa showing any type of motility following sperm processing.
Measured: Immediately after sperm processing on the day of oocyte retrieval.
Progressive Sperm Motility After Processing
Percentage of spermatozoa exhibiting progressive motility after sperm processing.
Measured: Immediately after sperm processing on the day of oocyte retrieval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fecundis Lab SL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano G Buffone, PhD, Principal investigator, Fecundis Lab SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478549
- Sponsor's protocol ID
- Fecundis_3
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Clinical Trial Evaluating the Safety of the HyperSperm Sperm Preparation Procedure.
- ClinicalTrials.gov ID
- NCT07478549
- Acronym / sponsor ID
- Fecundis_3
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Fecundis Lab SLUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Sperm Preparation | Active comparator | Device: Standard Sperm PreparationSperm samples in the control group will undergo traditional processing in the lab prior to insemination. |
| HyperSperm | Experimental | Device: HyperSpermSperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- General
- Couples undergoing in vitro fertilization (IVF) treatment.
- Planned use of fresh sperm samples obtained by masturbation.
- Female
- Age between 20 and 42 years.
Key exclusion criteria (11 listed)
- General
- Active sexually transmitted infection (STI).
- Use of donor sperm.
- Medical conditions contraindicating pregnancy or the IVF procedure.
- Female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Sperm PreparationStandard sperm preparation | Device | Standard Sperm Preparation |
| HyperSpermMulti-step sperm preparation | Device | HyperSperm |
Primary outcome
Euploidy Rate
Time frame: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).
Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.
10 secondary outcomes
Clinical Pregnancy Rate
Time frame: 5-7 weeks of gestation following embryo transfer.
Fertilization Rate
Time frame: Approximately 16-20 hours after insemination.
Cleavage Rate
Time frame: Day 2-3 after fertilization.
Blastocyst Formation Rate
Time frame: Day 5-6 after fertilization.
Embryo Quality at Cleavage Stage
Time frame: Day 3 after fertilization.
Embryo Quality at Blastocyst Stage
Time frame: Day 5-6 after fertilization.
Biochemical Pregnancy Rate
Time frame: Approximately 10-14 days after embryo transfer.
Progressive Motile Sperm Count After Processing
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Total Sperm Motility After Processing
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Progressive Sperm Motility After Processing
Time frame: Immediately after sperm processing on the day of oocyte retrieval.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariano G Buffone, PhD principal investigator
Fecundis Lab SL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Sperm Preparation and HyperSperm in people with Infertility, run by Fecundis Lab SL at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariano G Buffone, PhD (+54114783 2869 ext. +1314, buffone@fecundis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Euploidy Rate (time frame: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.